ID

36814

Description

Superior Colliculus Activity in Parkinson Disease: a Potential Marker?; ODM derived from: https://clinicaltrials.gov/show/NCT02488395

Link

https://clinicaltrials.gov/show/NCT02488395

Keywords

Versions (1)
  1. 6/12/19 6/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 12, 2019

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License

Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT02488395

English

Eligibility Parkinson's Disease NCT02488395

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
de novo parkinson's patients being just diagnosed (stage 1 according to the hoehn and yahr scale: first unilateral signs with no discomfort in everyday life) without a current dopaminergic treatment and who have not started their anti-parkinsonian treatment.
Description

Parkinson Disease de novo Hoehn and Yahr Stage | First sign Unilateral | Dopaminergic drug therapy Absent | Antiparkinson Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0030567
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C3639483
UMLS CUI [2,1]
C0449990
UMLS CUI [2,2]
C0205092
UMLS CUI [3,1]
C3267134
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0003405
UMLS CUI [4,2]
C0332197
both parkinson's patients and their age matching control must not present a major visual pathology (mainly in the retina) which may interfere with the visual task.
Description

Patients Parkinson Disease | Control Group Age Matching | Vision Disorder Major Absent | Retinal Disease Major Absent | Interference Task Visual

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C0009932
UMLS CUI [2,2]
C0001779
UMLS CUI [2,3]
C0150103
UMLS CUI [3,1]
C0042790
UMLS CUI [3,2]
C0205164
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0035309
UMLS CUI [4,2]
C0205164
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0521102
UMLS CUI [5,2]
C3540678
UMLS CUI [5,3]
C0234621
signed informed and free consent.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
matching controls must not present a neurological or psychiatric troubles.
Description

Control Group Matching | Nervous system problem Absent | Psychiatric problem Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0150103
UMLS CUI [2,1]
C0221571
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C1306597
UMLS CUI [3,2]
C0332197
for the matching controls: there are no contraindication on current treatments apart from those to treat other neurological disease than parkinson's disease or psychiatric troubles.
Description

Control Group Matching | Medical contraindication Absent Therapeutic procedure | Exception Therapeutic procedure Nervous system disorder Other | Exception Therapeutic procedure Psychiatric problem

Data type

boolean

Alias
UMLS CUI [1,1]
C0009932
UMLS CUI [1,2]
C0150103
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0027765
UMLS CUI [3,4]
C0205394
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0087111
UMLS CUI [4,3]
C1306597
for parkinson's patients: there are no contraindication on current treatments apart from those to treat neurological troubles including anti-parkinsonian treatment, or psychiatric troubles.
Description

Patients Parkinson Disease | Medical contraindication Absent Therapeutic procedure | Exception Therapeutic procedure Nervous system problem | Exception Antiparkinson Agents | Exception Therapeutic procedure Psychiatric problem

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0087111
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0221571
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0003405
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0087111
UMLS CUI [5,3]
C1306597
as a precaution, the investigators will check that no mri exam has been performed during the week preceding our fmri.
Description

MRI Preceding Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0024485
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
parkinson's patients with important tremor limiting the validity of the fmri acquisition.
Description

Patients Parkinson Disease | Tremor Important | Validity fMRI Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0030567
UMLS CUI [2,1]
C0040822
UMLS CUI [2,2]
C3898777
UMLS CUI [3,1]
C2349101
UMLS CUI [3,2]
C0376335
UMLS CUI [3,3]
C0439801
adult under supervision
Description

Adult Supervision

Data type

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0038842
incapacity to understand the consent explanations.
Description

Informed Consent Comprehension Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
impossibility to participate to the whole experimental protocol.
Description

Study Subject Participation Status Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1272705
no affiliation to a health insurance.
Description

Health Insurance Affiliation Lacking

Data type

boolean

Alias
UMLS CUI [1,1]
C0021682
UMLS CUI [1,2]
C1510825
UMLS CUI [1,3]
C0332268
consent not signed by a participant or refusal by the participant to participate to the experiment.
Description

Informed Consent Lacking | Experiment Participation Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0332268
UMLS CUI [2,1]
C0681814
UMLS CUI [2,2]
C0679823
UMLS CUI [2,3]
C1705116
pregnancy or breast feeding woman.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
administrative or justice freedom restricted participant.
Description

Study Subject Freedom Restricted

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0016694
UMLS CUI [1,3]
C0443288
exclusion criteria specific for mri:
Description

Exclusion Criteria MRI

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0024485
pacemaker, neurosensorial stimulator or implanted defibrillator.
Description

Artificial cardiac pacemaker | Neurostimulator | Defibrillator implant

Data type

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0582124
UMLS CUI [3]
C0850291
presence of ocular or cerebral ferromagnetic material.
Description

Ferromagnet Material Ocular | Ferromagnet Material Cerebral

Data type

boolean

Alias
UMLS CUI [1,1]
C3178787
UMLS CUI [1,2]
C0520510
UMLS CUI [1,3]
C0015392
UMLS CUI [2,1]
C3178787
UMLS CUI [2,2]
C0520510
UMLS CUI [2,3]
C0006104
respiratory disease (i.e. asthma), cardio-vascular deficits, claustrophobia
Description

Respiration Disorders | Asthma | Cardiovascular impairment | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1]
C0035204
UMLS CUI [2]
C0004096
UMLS CUI [3]
C0848757
UMLS CUI [4]
C0008909
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Similar models

Eligibility Parkinson's Disease NCT02488395

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Parkinson Disease de novo Hoehn and Yahr Stage | First sign Unilateral | Dopaminergic drug therapy Absent | Antiparkinson Agents Absent
Item
de novo parkinson's patients being just diagnosed (stage 1 according to the hoehn and yahr scale: first unilateral signs with no discomfort in everyday life) without a current dopaminergic treatment and who have not started their anti-parkinsonian treatment.
boolean
C0030567 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C3639483 (UMLS CUI [1,3])
C0449990 (UMLS CUI [2,1])
C0205092 (UMLS CUI [2,2])
C3267134 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0003405 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Patients Parkinson Disease | Control Group Age Matching | Vision Disorder Major Absent | Retinal Disease Major Absent | Interference Task Visual
Item
both parkinson's patients and their age matching control must not present a major visual pathology (mainly in the retina) which may interfere with the visual task.
boolean
C0030705 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0009932 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C0150103 (UMLS CUI [2,3])
C0042790 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0035309 (UMLS CUI [4,1])
C0205164 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0521102 (UMLS CUI [5,1])
C3540678 (UMLS CUI [5,2])
C0234621 (UMLS CUI [5,3])
Informed Consent
Item
signed informed and free consent.
boolean
C0021430 (UMLS CUI [1])
Control Group Matching | Nervous system problem Absent | Psychiatric problem Absent
Item
matching controls must not present a neurological or psychiatric troubles.
boolean
C0009932 (UMLS CUI [1,1])
C0150103 (UMLS CUI [1,2])
C0221571 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1306597 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Control Group Matching | Medical contraindication Absent Therapeutic procedure | Exception Therapeutic procedure Nervous system disorder Other | Exception Therapeutic procedure Psychiatric problem
Item
for the matching controls: there are no contraindication on current treatments apart from those to treat other neurological disease than parkinson's disease or psychiatric troubles.
boolean
C0009932 (UMLS CUI [1,1])
C0150103 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0027765 (UMLS CUI [3,3])
C0205394 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C1306597 (UMLS CUI [4,3])
Patients Parkinson Disease | Medical contraindication Absent Therapeutic procedure | Exception Therapeutic procedure Nervous system problem | Exception Antiparkinson Agents | Exception Therapeutic procedure Psychiatric problem
Item
for parkinson's patients: there are no contraindication on current treatments apart from those to treat neurological troubles including anti-parkinsonian treatment, or psychiatric troubles.
boolean
C0030705 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0221571 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0003405 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0087111 (UMLS CUI [5,2])
C1306597 (UMLS CUI [5,3])
MRI Preceding Absent
Item
as a precaution, the investigators will check that no mri exam has been performed during the week preceding our fmri.
boolean
C0024485 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Patients Parkinson Disease | Tremor Important | Validity fMRI Limited
Item
parkinson's patients with important tremor limiting the validity of the fmri acquisition.
boolean
C0030705 (UMLS CUI [1,1])
C0030567 (UMLS CUI [1,2])
C0040822 (UMLS CUI [2,1])
C3898777 (UMLS CUI [2,2])
C2349101 (UMLS CUI [3,1])
C0376335 (UMLS CUI [3,2])
C0439801 (UMLS CUI [3,3])
Adult Supervision
Item
adult under supervision
boolean
C0001675 (UMLS CUI [1,1])
C0038842 (UMLS CUI [1,2])
Informed Consent Comprehension Unable
Item
incapacity to understand the consent explanations.
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Subject Participation Status Unsuccessful
Item
impossibility to participate to the whole experimental protocol.
boolean
C2348568 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Health Insurance Affiliation Lacking
Item
no affiliation to a health insurance.
boolean
C0021682 (UMLS CUI [1,1])
C1510825 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Informed Consent Lacking | Experiment Participation Refused
Item
consent not signed by a participant or refusal by the participant to participate to the experiment.
boolean
C0021430 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0681814 (UMLS CUI [2,1])
C0679823 (UMLS CUI [2,2])
C1705116 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnancy or breast feeding woman.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Freedom Restricted
Item
administrative or justice freedom restricted participant.
boolean
C0681850 (UMLS CUI [1,1])
C0016694 (UMLS CUI [1,2])
C0443288 (UMLS CUI [1,3])
Exclusion Criteria MRI
Item
exclusion criteria specific for mri:
boolean
C0680251 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
Artificial cardiac pacemaker | Neurostimulator | Defibrillator implant
Item
pacemaker, neurosensorial stimulator or implanted defibrillator.
boolean
C0030163 (UMLS CUI [1])
C0582124 (UMLS CUI [2])
C0850291 (UMLS CUI [3])
Ferromagnet Material Ocular | Ferromagnet Material Cerebral
Item
presence of ocular or cerebral ferromagnetic material.
boolean
C3178787 (UMLS CUI [1,1])
C0520510 (UMLS CUI [1,2])
C0015392 (UMLS CUI [1,3])
C3178787 (UMLS CUI [2,1])
C0520510 (UMLS CUI [2,2])
C0006104 (UMLS CUI [2,3])
Respiration Disorders | Asthma | Cardiovascular impairment | Claustrophobia
Item
respiratory disease (i.e. asthma), cardio-vascular deficits, claustrophobia
boolean
C0035204 (UMLS CUI [1])
C0004096 (UMLS CUI [2])
C0848757 (UMLS CUI [3])
C0008909 (UMLS CUI [4])
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